A Phase 2 interventional study of simlukafusp alfa and Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody in Advanced/Metastatic Head and Neck, Oesophageal and Cervical Cancers, sponsored by Hoffmann-La Roche. Terminated at 44 sites in 15 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-21.
Sponsored by Hoffmann-La Roche · Phase 2, Interventional, and Treatment
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Among 18 studies testing gemcitabine in Uterine Cervical Neoplasms — 4 open to participants now, 4 under way, 3 of them phase 3. Gemcitabine · Uterine Cervical Neoplasms.
Among the 18 studies testing gemcitabine in Uterine Cervical Neoplasms, this one is the 6th largest by enrollment of the 16 interventional ones that give a count, is one of 2 that started in 2018, is one of 6 in phase 2, and was the 15th registered.
2,366 studies on the registry are indexed under Uterine Cervical Neoplasms; 677 are open to participants now.
Browse Uterine Cervical Neoplasms studies →4 of the 18 studies testing gemcitabine in Uterine Cervical Neoplasms are open now, in 3 countries. Recruiting first, the newest first:
Hospital do Coracao · Sites in Brazil
Ages 18–70 · Women only
Chuangzhen Chen · Sites in China
Ages 18–70 · Women only
National Institute of Cancerología · Sites in Mexico
Ages 18+ · Women only
National Institute of Cancerología · Sites in Mexico
Ages 18–70 · Women only
By country, each count listing its studies:
Gemcitabine: first FDA approval 1996 (GEMZAR). What it is approved for, and how studies give it, is on its page →
Of the 474 Uterine Cervical Neoplasms studies recruiting now, 243 (51%) set no upper age limit and 191 (40%) stop at 75 or younger; 20 take children under 18; 69 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
18 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 7 · Phase 3 8
First in 1999; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 256 is above the median of 100 across 1,738 interventional studies indexed under Uterine Cervical Neoplasms.
Median enrollment 95 across the 16 interventional studies. Of the 11 that completed or were terminated, 4 (36%) have results posted.
This tab as a report to print or save as PDF → With an account.
2 of 18 have an industry lead sponsor. The 10 most frequent:
Hoffmann-La Roche is the lead sponsor of 2,101 studies on the registry; 88 are open to participants now.
Of its 330 completed or terminated interventional studies of FDA-regulated products, 248 (75%) have results posted.
Hoffmann-La Roche has 5 studies filed under Uterine Cervical Neoplasms — fewer than ten, so there is no comparison to draw.
2 of the studies testing gemcitabine in Uterine Cervical Neoplasms that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06156514Phase 3National Institute of CancerologíaEvaluation of Concomitant Chemo-radiotherapy With Cisplatine vs Gemcitabin in Locally Advanced Cervicouterine Cancer | 2026-11-30 |
| NCT05764044Phase 3Hospital do CoracaoAdjuvant Chemotherapy in cfHPV-DNA Plasma Positive Patients: A Biomarker In Locally Advanced Cervical Cancer | 2026-12-31 |
Add all 2 to your calendar (.ics) → With an account.
Among the 18 studies testing gemcitabine in Uterine Cervical Neoplasms, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This is an open-label, multicenter, basket trial Phase II study to evaluate the antitumor activity of simlukafusp alfa in combination with atezolizumab in participants with advanced and/or metastatic solid tumors. Currently the focus is on participants with Head and Neck, oesophageal and cervical cancers with confirmed squamous cell carcinoma histology type.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Biopsies are not applicable to participants in Cohorts G, H, K, and L presenting with a single target lesion and absence of any non-target lesion.
Participants with unilateral pleural effusion (indications other than NSCLC) are eligible if they fulfill both of the following:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Checkpoint Inhibitor (CPI)-Naïve Participants with non-small-cell lung cancer (NSCLC) who have not received CPI therapy previously will receive simlukafusp alfa intravenous (IV) infusion once in a week (QW) for first 5 doses, and once in 2 weeks (Q2W) for remaining doses up to maximum 36 months. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered in combination Q2W at a dose of 840 mg. Tumor biopsies: collection of fresh tumor biopsies (at baseline and on-treatment) will be optional.
Drug: simlukafusp alfa · Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody
CPI-Experienced Participants (NSCLC) who have received CPI therapy previously will receive simlukafusp alfa intravenous (IV) infusion once in a week (QW) for first 5 doses, and once in 2 weeks (Q2W) for remaining doses up to maximum 36 months. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered in combination Q2W at a dose of 840 mg. Tumor biopsies: 2 mandatory fresh tumor biopsies, one at baseline and one on-treatment, will be collected. Additional on-treatment biopsies will be optional.
Drug: simlukafusp alfa · Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody
This is a mandatory biopsy cohort based on the treatment's safety and preliminary activity analysis to enroll CPI-Naive Participants. Participants (NSCLC) will receive simlukafusp alfa intravenous (IV) infusion once in a week (QW) for first 5 doses, and once in 2 weeks (Q2W) for remaining doses up to maximum 36 months. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered in combination Q2W at a dose of 840 mg. Tumor biopsies: 2 mandatory fresh tumor biopsies, one at baseline and one on-treatment, will be collected. Additional on-treatment biopsies will be optional.
Drug: simlukafusp alfa · Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody
CPI Experienced Participants (NSCLC) who were previously treated with platinum and docetaxel. Participants will receive simlukafusp alfa intravenous (IV) infusion once in a week (QW) for first 5 doses, and once in 2 weeks (Q2W) for remaining doses up to maximum 36 months. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered in combination Q2W at a dose of 840 mg. Tumor biopsies: 2 mandatory fresh tumor biopsies, one at baseline and one on-treatment, will be collected. Additional on-treatment biopsies will be optional.
Drug: simlukafusp alfa · Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody
CPI Experienced Participants (NSCLC) who were previously treated with platinum and docetaxel. Participants will receive simlukafusp alfa intravenous (IV) infusion once in 3 weeks (Q3W) up to maximum 36 months. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered in combination Q3W at a dose of 1200 mg. Tumor biopsies: 2 mandatory fresh tumor biopsies, one at baseline and one on-treatment, will be collected. Additional on-treatment biopsies will be optional.
Drug: simlukafusp alfa · Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody
CPI Experienced Participants (NSCLC) who were previously treated with platinum and docetaxel will receive a single-agent gemcitabine or vinorelbine as per approved protocol. Tumor biopsies: 2 mandatory fresh tumor biopsies, one at baseline and one on-treatment, will be collected. Additional on-treatment biopsies will be optional.
Drug: Gemcitabine · Drug: Vinorelbine
This cohort will enroll participants (NSCLC) with High-Tumor PD-L1 Expression who have not received any prior systemic therapy. Participants will receive simlukafusp alfa intravenous (IV) infusion once in a week (QW) for first 5 doses, and once in 2 weeks (Q2W) for remaining doses up to maximum 36 months. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered in combination Q2W at a dose of 840 mg. Tumor biopsies: 2 mandatory fresh tumor biopsies, one at baseline and one on-treatment, will be collected. Additional on-treatment biopsies will be optional.
Drug: simlukafusp alfa · Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody
This cohort will enroll participants (NSCLC) with High-Tumor PD-L1 Expression who have not received any prior systemic therapy. Participants will receive simlukafusp alfa IV infusion in combination with atezolizumab Q3W. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered at a dose of 1200 mg. Tumor biopsies: 2 mandatory fresh tumor biopsies, one at baseline and one on-treatment, will be collected. Additional on-treatment biopsies will be optional.
Drug: simlukafusp alfa · Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody
CPI-experienced, docetaxel naive participants (NSCLC) who experienced disease progression during or following treatment with a platinum - containing regimen. Participants will receive combination of simlukafusp alfa and atezolizumab in a Q3W schedule. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered at a dose of 1200 mg. Tumor biopsies: one mandatory fresh tumor biopsy will be collected at baseline. Additional on-treatment biopsies will be optional.
Drug: simlukafusp alfa · Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody
CPI-naïve SCC of the head and neck (SCCHN) (20 response-evaluable participants), mandatory biopsies. Participants in cohort G Part III will receive simlukafusp alfa Q3W in combination with atezolizumab Q3W. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered at a dose of 1200 mg. Tumor biopsies: one mandatory fresh tumor biopsy will be collected at baseline. Additional on-treatment biopsies will be optional. Biopsies are not applicable to participants presenting with a single target lesion and absence of any non-target lesion.
Drug: simlukafusp alfa · Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody
Previously treated, CPI-experienced squamous cell carcinoma head and heck cancer (20 response evaluable participants), mandatory biopsies. Participants in cohort H Part III will receive simlukafusp alfa Q3W in combination with atezolizumab Q3W. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered at a dose of 1200 mg. Tumor biopsies: one mandatory fresh tumor biopsy will be collected at baseline. Additional on-treatment biopsies will be optional. Biopsies are not applicable to participants presenting with a single target lesion and absence of any non-target lesion.
Drug: simlukafusp alfa · Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody
Previously treated, CPI-naïve squamous esophageal cancer (20 response evaluable participants), mandatory biopsies. Participants in cohort I Part III will receive simlukafusp alfa Q3W in combination with atezolizumab Q3W. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered at a dose of 1200 mg. Tumor biopsies: one mandatory fresh tumor biopsy will be collected at baseline. Additional on-treatment biopsies will be optional.
Drug: simlukafusp alfa · Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody
Previously treated, CPI-naïve squamous cervical cancer (20 response evaluable participants): mandatory biopsy. Participants in cohort J Part III will receive simlukafusp alfa Q3W in combination with atezolizumab Q3W. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered at a dose of 1200 mg. Tumor biopsies: one mandatory fresh tumor biopsy will be collected at baseline. Additional on-treatment biopsies will be optional.
Drug: simlukafusp alfa · Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody
CPI-naïve SCC of the head and neck (SCCHN) (20 response-evaluable participants), mandatory biopsies. Participants in cohort K Part III will receive simlukafusp alfa QW in combination with atezolizumab Q2W for 4 weeks followed by simlukafusp alfa in combination with atezolizumab Q2W. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered at a dose of 840 mg. Tumor biopsies: one mandatory fresh tumor biopsy will be collected at baseline. Additional on-treatment biopsies will be optional. Biopsies are not applicable to participants presenting with a single target lesion and absence of any non-target lesion.
Drug: simlukafusp alfa · Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody
Previously treated, CPI-experienced squamous cell carcinoma head and neck cancer (20 response evaluable participants), mandatory biopsies. Participants in cohort L Part III will receive simlukafusp alfa QW in combination with atezolizumab Q2W for 4 weeks followed by simlukafusp alfa in combination with atezolizumab Q2W. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered at a dose of 840 mg. Tumor biopsies: one mandatory fresh tumor biopsy will be collected at baseline. Additional on-treatment biopsies will be optional. Biopsies are not applicable to participants presenting with a single target lesion and absence of any non-target lesion.
Drug: simlukafusp alfa · Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody
Esophageal SCC participants will receive simlukafusp alfa QW in combination with atezolizumab Q2W for 4 weeks followed by simlukafusp alfa in combination with atezolizumab Q2W. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered at a dose of 840 mg. Tumor biopsies: one mandatory fresh tumor biopsy will be collected at baseline. Additional on-treatment biopsies will be optional.
Drug: simlukafusp alfa · Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody
Cervical SCC participants will receive simlukafusp alfa QW in combination with atezolizumab Q2W for 4 weeks followed by simlukafusp alfa in combination with atezolizumab Q2W. Simlukafusp alfa will be administered at a 10 mg flat dose. Atezolizumab IV infusion will be administered at a dose of 840 mg. Tumor biopsies: one mandatory fresh tumor biopsy will be collected at baseline. Additional on-treatment biopsies will be optional.
Drug: simlukafusp alfa · Drug: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody
simlukafusp alfa will be administered as per the dosage regimen mentioned in arm descriptions.
Also known as: RO6874281
Atezolizumab will be administered as per the dosage regimen mentioned in arm descriptions.
Single-agent treatment administered as per approved protocol.
Single-agent treatment administered as per approved protocol.
Percentage of Participants With Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
ORR was defined as the percentage of participants with observed tumor response of complete response (CR), or partial response (PR) determined according to RECIST version 1.1. CR was defined as the disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to \<10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The percentages of participants are rounded off to the nearest single decimal point.
Time frame: Baseline up to disease progression or study treatment discontinuation (up to 38 months)
Percentage of Participants With Disease Control Rate (DCR) Determined According to RECIST Version 1.1
DCR was defined as the percentage of participants with observed tumor response of CR, PR or stable disease (SD) determined according to RECIST version 1.1. CR was defined as the disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline (nadir). The percentages of participants are rounded off to the nearest single decimal point.
Time frame: Baseline up to disease progression or study treatment discontinuation (up to 38 months)
Duration of Response (DoR) According to RECIST Version 1.1
DoR was determined for participants who had a best overall response of CR or PR. CR was defined as the disappearance of all target lesions with a reduction in target/non-target pathological lymph nodes to \< 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. DoR was defined as the time from first occurrence of a documented objective response until the time of documented disease progression or death from any cause during treatment, whichever occurs first. Participants that did not have documented progressive disease or death during the study were censored at the day of the last tumor assessment.
Time frame: From first occurrence of documented CR or PR up to disease progression or study treatment discontinuation (assessed every 8 weeks after study treatment start for the first year, and every 12 weeks thereafter, up to 38 months)
Progression-Free Survival (PFS) According to RECIST Version 1.1
PFS was defined as the time from study treatment initiation (Cycle 1 Day 1 \[1 cycle=14 days for QW/Q2W cohorts; 1 cycle=21 days for Q3W cohorts\]) to the first occurrence of documented disease progression (based on Investigator's assessment) or death from any cause during treatment, whichever occurs first. Participants that did not have documented progressive disease or death during the study were censored at the day of the last tumor assessment.
Time frame: Study treatment initiation up to disease progression or study treatment discontinuation (up to 38 months)
Overall Survival (OS)
OS was defined as the time from the first dose of study treatment to the time of death from any cause on study. Participants who were still alive at the time of analysis were censored at the last date known alive.
Time frame: From first dose of study treatment up to death due to any cause (up to approximately 47 months)
Percentage of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time frame: Baseline up to end of the study (up to approximately 47 months)
Percentage of Participants by Programmed Death-Ligand 1 (PD-L1) Status According to Immunohistochemical Methods
Time frame: Baseline
Change From Baseline in Density of Cluster of Differentiation (CD) 8 Positive (CD8+) Cells According to Immunohistochemical Methods
Time frame: Baseline up 2 months
Change From Baseline in Density of Cluster of Differentiation 3 Negative (CD3-) Perforin Positive Cells According to Immunohistochemical Methods
Time frame: Baseline up to 2 months
Change From Baseline in Density of PD-L1 According to Immunohistochemical Methods
Time frame: Baseline up to 2 months
Participants took part in the study at 42 investigative sites in Belgium, France, Germany, Israel, Korea, New Zealand, Poland, Russia, Singapore, Spain, Switzerland, Taiwan, Turkey, United Kingdom, USA from 19 February 2018 to 30 December 2021
| Milestone | NSCLC: Part I Cohort A (QW/Q2W) | NSCLC: Part I Cohort B (QW/Q2W) | NSCLC: Part I Cohort D, Arm 1 (QW/Q2W) | NSCLC: Part I Cohort D, Arm 2 (Q3W) | NSCLC: Part I Cohort D, Arm 3 (Q3W) | NSCLC: Part I Cohort F (Q3W) | NSCLC: Part II Cohort E, Arm 1 (QW/Q2W) | NSCLC: Part II Cohort E, Arm 2 (Q3W) | SCCHN: Part III Cohort G (Q3W) | SCCHN: Part III Cohort H (Q3W) | ESCC: Part III Cohort I (Q3W) | CSCC: Part III Cohort J (Q3W) | SCCHN: Part III Cohort K (QW/Q2W) | ESCC: Part III Cohort M (QW/Q2W) | CSCC: Part III Cohort N (QW/Q2W) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 26 | 32 | 3 | 5 | 2 | 22 | 3 | 2 | 23 | 30 | 33 | 47 | 25 | 2 | 1 |
| Response evaluable population | 26 | 32 | 3 | 5 | 0 | 21 | 3 | 2 | 22 | 28 | 32 | 44 | 25 | 2 | 1 |
| Completed | 4 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 2 | 6 | 0 | 0 | 0 |
| Not completed | 22 | 31 | 3 | 5 | 2 | 21 | 3 | 2 | 22 | 30 | 31 | 41 | 25 | 2 | 1 |
| Withdrew: Death | 12 | 21 | 2 | 5 | 1 | 12 | 1 | 1 | 12 | 20 | 21 | 21 | 14 | 2 | 1 |
| Withdrew: Lost to follow-up | 1 | 3 | 0 | 0 | 0 | 2 | 1 | 0 | 1 | 2 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Reason not specified | 3 | 0 | 0 | 0 | 0 | 3 | 1 | 0 | 0 | 1 | 2 | 6 | 1 | 0 | 0 |
| Withdrew: Progressive disease | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 2 | 1 | 1 | 0 | 1 | 0 | 0 |
| Withdrew: Site terminated by sponsor | 5 | 5 | 0 | 0 | 1 | 3 | 0 | 1 | 4 | 5 | 3 | 11 | 6 | 0 | 0 |
| Withdrew: Symptomatic deterioration | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 3 | 2 | 3 | 0 | 0 |
ORR was defined as the percentage of participants with observed tumor response of complete response (CR), or partial response (PR) determined according to RECIST version 1.1. CR was defined as the disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to \<10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The percentages of participants are rounded off to the nearest single decimal point.
| percentage of participants | NSCLC: Part I Cohort A (QW/Q2W) | NSCLC: Part I Cohort B (QW/Q2W) | NSCLC: Part I Cohort D, Arm 1 (QW/Q2W) | NSCLC: Part I Cohort D, Arm 2 (Q3W) | NSCLC: Part I Cohort D, Arm 3 (Q3W) | NSCLC: Part I Cohort F (Q3W) | NSCLC: Part II Cohort E, Arm 1 (QW/Q2W) | NSCLC: Part II Cohort E, Arm 2 (Q3W) | SCCHN: Part III Cohort G (Q3W) | SCCHN: Part III Cohort H (Q3W) | ESCC: Part III Cohort I (Q3W) | CSCC: Part III Cohort J (Q3W) | SCCHN: Part III Cohort K (QW/Q2W) | ESCC: Part III Cohort M (QW/Q2W) | CSCC: Part III Cohort N (QW/Q2W) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Percentage of Participants With Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | 19.2 (8.51 to 37.88) | 6.3 (1.73 to 20.15) | 0 (0.00 to 56.15) | 0 (0.00 to 43.45) | — | 4.8 (0.85 to 22.67) | 66.7 (20.77 to 93.85) | 50.0 (9.45 to 90.55) | 18.2 (7.31 to 38.52) | 3.6 (0.63 to 17.71) | 21.9 (11.02 to 38.75) | 27.3 (16.35 to 41.85) | 4.0 (0.71 to 19.54) | 0 (0.00 to 65.76) | 0 (0.00 to 79.35) |
DCR was defined as the percentage of participants with observed tumor response of CR, PR or stable disease (SD) determined according to RECIST version 1.1. CR was defined as the disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline (nadir). The percentages of participants are rounded off to the nearest single decimal point.
| percentage of participants | NSCLC: Part I Cohort A (QW/Q2W) | NSCLC: Part I Cohort B (QW/Q2W) | NSCLC: Part I Cohort D, Arm 1 (QW/Q2W) | NSCLC: Part I Cohort D, Arm 2 (Q3W) | NSCLC: Part I Cohort D, Arm 3 (Q3W) | NSCLC: Part I Cohort F (Q3W) | NSCLC: Part II Cohort E, Arm 1 (QW/Q2W) | NSCLC: Part II Cohort E, Arm 2 (Q3W) | SCCHN: Part III Cohort G (Q3W) | SCCHN: Part III Cohort H (Q3W) | ESCC: Part III Cohort I (Q3W) | CSCC: Part III Cohort J (Q3W) | SCCHN: Part III Cohort K (QW/Q2W) | ESCC: Part III Cohort M (QW/Q2W) | CSCC: Part III Cohort N (QW/Q2W) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Percentage of Participants With Disease Control Rate (DCR) Determined According to RECIST Version 1.1 | 53.8 (35.46 to 71.24) | 62.5 (45.25 to 77.07) | 0 (0.00 to 56.15) | 20.0 (3.62 to 62.45) | — | 57.1 (36.55 to 75.53) | 66.7 (20.77 to 93.85) | 50.0 (9.45 to 90.55) | 50.0 (30.72 to 69.28) | 14.3 (5.70 to 31.49) | 43.8 (28.17 to 60.67) | 68.2 (53.44 to 80.00) | 36.0 (20.25 to 55.48) | 50.0 (9.45 to 90.55) | 0 (0.00 to 79.35) |
DoR was determined for participants who had a best overall response of CR or PR. CR was defined as the disappearance of all target lesions with a reduction in target/non-target pathological lymph nodes to \< 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. DoR was defined as the time from first occurrence of a documented objective response until the time of documented disease progression or death from any cause during treatment, whichever occurs first. Participants that did not have documented progressive disease or death during the study were censored at the day of the last tumor assessment.
No measurements were reported for this outcome.
PFS was defined as the time from study treatment initiation (Cycle 1 Day 1 \[1 cycle=14 days for QW/Q2W cohorts; 1 cycle=21 days for Q3W cohorts\]) to the first occurrence of documented disease progression (based on Investigator's assessment) or death from any cause during treatment, whichever occurs first. Participants that did not have documented progressive disease or death during the study were censored at the day of the last tumor assessment.
| months | NSCLC: Part I Cohort A (QW/Q2W) | NSCLC: Part I Cohort B (QW/Q2W) | NSCLC: Part I Cohort D, Arm 1 (QW/Q2W) | NSCLC: Part I Cohort D, Arm 2 (Q3W) | NSCLC: Part I Cohort D, Arm 3 (Q3W) | NSCLC: Part I Cohort F (Q3W) | NSCLC: Part II Cohort E, Arm 1 (QW/Q2W) | NSCLC: Part II Cohort E, Arm 2 (Q3W) | SCCHN: Part III Cohort G (Q3W) | SCCHN: Part III Cohort H (Q3W) | ESCC: Part III Cohort I (Q3W) | CSCC: Part III Cohort J (Q3W) | SCCHN: Part III Cohort K (QW/Q2W) | ESCC: Part III Cohort M (QW/Q2W) | CSCC: Part III Cohort N (QW/Q2W) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Progression-Free Survival (PFS) According to RECIST Version 1.1 | 3.5 (1.7 to 7.4) | 3.7 (3.1 to 5.2) | 2.0 (1.7 to NA) | 2.0 (1.9 to NA) | — | 3.5 (1.9 to 5.5) | NA (2.6 to NA) | 10.5 (1.9 to NA) | 2.5 (1.8 to 5.6) | 1.9 (1.8 to 1.9) | 1.9 (1.8 to 3.7) | 3.7 (3.3 to 9.0) | 1.9 (1.6 to 3.2) | 2.6 (1.6 to NA) | 1.9 (NA to NA) |
OS was defined as the time from the first dose of study treatment to the time of death from any cause on study. Participants who were still alive at the time of analysis were censored at the last date known alive.
| months | NSCLC: Part I Cohort A (QW/Q2W) | NSCLC: Part I Cohort B (QW/Q2W) | NSCLC: Part I Cohort D, Arm 1 (QW/Q2W) | NSCLC: Part I Cohort D, Arm 2 (Q3W) | NSCLC: Part I Cohort D, Arm 3 (Q3W) | NSCLC: Part I Cohort F (Q3W) | NSCLC: Part II Cohort E, Arm 1 (QW/Q2W) | NSCLC: Part II Cohort E, Arm 2 (Q3W) | SCCHN: Part III Cohort G (Q3W) | SCCHN: Part III Cohort H (Q3W) | ESCC: Part III Cohort I (Q3W) | CSCC: Part III Cohort J (Q3W) | SCCHN: Part III Cohort K (QW/Q2W) | ESCC: Part III Cohort M (QW/Q2W) | CSCC: Part III Cohort N (QW/Q2W) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Survival (OS) | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) | — | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) |
An AE is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
| percentage of participants | NSCLC: Part I Cohort A (QW/Q2W) | NSCLC: Part I Cohort B (QW/Q2W) | NSCLC: Part I Cohort D, Arm 1 (QW/Q2W) | NSCLC: Part I Cohort D, Arm 2 (Q3W) | NSCLC: Part I Cohort D, Arm 3 (Q3W) | NSCLC: Part I Cohort F (Q3W) | NSCLC: Part II Cohort E, Arm 1 (QW/Q2W) | NSCLC: Part II Cohort E, Arm 2 (Q3W) | SCCHN: Part III Cohort G (Q3W) | SCCHN: Part III Cohort H (Q3W) | ESCC: Part III Cohort I (Q3W) | CSCC: Part III Cohort J (Q3W) | SCCHN: Part III Cohort K (QW/Q2W) | ESCC: Part III Cohort M (QW/Q2W) | CSCC: Part III Cohort N (QW/Q2W) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Percentage of Participants With Adverse Events (AEs) | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Collected over Baseline up to end of the study (up to approximately 47 months). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NSCLC: Part I Cohort A (QW/Q2W) | 12/26 (46.2%) | 13/26 (50%) | 25/26 (96.2%) |
| NSCLC: Part I Cohort B (QW/Q2W) | 21/32 (65.6%) | 25/32 (78.1%) | 32/32 (100%) |
| NSCLC: Part I Cohort D, Arm 1 (QW/Q2W) | 3/3 (100%) | 0/3 (0%) | 3/3 (100%) |
| NSCLC: Part I Cohort D, Arm 2 (Q3W) | 5/5 (100%) | 3/5 (60%) | 5/5 (100%) |
| NSCLC: Part I Cohort D, Arm 3 (Q3W) | 1/2 (50%) | 2/2 (100%) | 2/2 (100%) |
| NSCLC: Part I Cohort F (Q3W) | 12/22 (54.5%) | 14/22 (63.6%) | 21/22 (95.5%) |
| NSCLC: Part II Cohort E, Arm 1 (QW/Q2W) | 1/3 (33.3%) | 1/3 (33.3%) | 3/3 (100%) |
| NSCLC: Part II Cohort E, Arm 2 (Q3W) | 1/2 (50%) | 1/2 (50%) | 2/2 (100%) |
| SCCHN: Part III Cohort G (Q3W) | 14/23 (60.9%) | 15/23 (65.2%) | 23/23 (100%) |
| SCCHN: Part III Cohort H (Q3W) | 20/30 (66.7%) | 22/30 (73.3%) | 29/30 (96.7%) |
| ESCC: Part III Cohort I (Q3W) | 21/33 (63.6%) | 20/33 (60.6%) | 33/33 (100%) |
| CSCC: Part III Cohort J (Q3W) | 21/47 (44.7%) | 32/47 (68.1%) | 47/47 (100%) |
| SCCHN: Part III Cohort K (QW/Q2W) | 14/25 (56%) | 14/25 (56%) | 24/25 (96%) |
| ESCC: Part III Cohort M (QW/Q2W) | 2/2 (100%) | 1/2 (50%) | 2/2 (100%) |
| CSCC: Part III Cohort N (QW/Q2W) | 1/1 (100%) | 1/1 (100%) | 1/1 (100%) |
| Event | NSCLC: Part I Cohort A (QW/Q2W) | NSCLC: Part I Cohort B (QW/Q2W) | NSCLC: Part I Cohort D, Arm 1 (QW/Q2W) | NSCLC: Part I Cohort D, Arm 2 (Q3W) | NSCLC: Part I Cohort D, Arm 3 (Q3W) | NSCLC: Part I Cohort F (Q3W) | NSCLC: Part II Cohort E, Arm 1 (QW/Q2W) | NSCLC: Part II Cohort E, Arm 2 (Q3W) | SCCHN: Part III Cohort G (Q3W) | SCCHN: Part III Cohort H (Q3W) | ESCC: Part III Cohort I (Q3W) | CSCC: Part III Cohort J (Q3W) | SCCHN: Part III Cohort K (QW/Q2W) | ESCC: Part III Cohort M (QW/Q2W) | CSCC: Part III Cohort N (QW/Q2W) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| UROSTOMY COMPLICATIONInjury, poisoning and procedural complications | 0/26 | 0/32 | 0/3 | 0/5 | 0/2 | 0/22 | 0/3 | 0/2 | 0/23 | 0/30 | 0/33 | 0/47 | 0/25 | 0/2 | 1/1 |
| DEVICE DISLOCATIONProduct Issues | 0/26 | 0/32 | 0/3 | 0/5 | 0/2 | 0/22 | 0/3 | 0/2 | 0/23 | 0/30 | 0/33 | 0/47 | 0/25 | 0/2 | 1/1 |
| ACUTE KIDNEY INJURYRenal and urinary disorders | 0/26 | 1/32 | 0/3 | 0/5 | 0/2 | 0/22 | 0/3 | 0/2 | 1/23 | 0/30 | 2/33 | 2/47 | 0/25 | 0/2 | 1/1 |
| URINARY TRACT OBSTRUCTIONRenal and urinary disorders | 0/26 | 0/32 | 0/3 | 0/5 | 0/2 | 0/22 | 0/3 | 0/2 | 0/23 | 0/30 | 0/33 | 0/47 | 0/25 | 0/2 | 1/1 |
| ABDOMINAL PAIN UPPERGastrointestinal disorders | 0/26 | 0/32 | 0/3 | 0/5 | 1/2 | 0/22 | 0/3 | 0/2 | 0/23 | 0/30 | 0/33 | 0/47 | 0/25 | 0/2 | 0/1 |
| RECTAL HAEMORRHAGEGastrointestinal disorders | 0/26 | 0/32 | 0/3 | 0/5 | 1/2 | 0/22 | 0/3 | 0/2 | 0/23 | 0/30 | 0/33 | 1/47 | 1/25 | 0/2 | 0/1 |
| FATIGUEGeneral disorders | 0/26 | 1/32 | 0/3 | 0/5 | 0/2 | 0/22 | 0/3 | 1/2 | 0/23 | 1/30 | 0/33 | 0/47 | 0/25 | 0/2 | 0/1 |
| PLEURAL INFECTIONInfections and infestations | 0/26 | 0/32 | 0/3 | 0/5 | 0/2 | 0/22 | 0/3 | 1/2 | 0/23 | 0/30 | 0/33 | 0/47 | 0/25 | 0/2 | 0/1 |
| PNEUMONIA BACTERIALInfections and infestations | 0/26 | 0/32 | 0/3 | 0/5 | 0/2 | 0/22 | 0/3 | 0/2 | 0/23 | 0/30 | 0/33 | 0/47 | 0/25 | 1/2 | 0/1 |
| INFUSION RELATED REACTIONInjury, poisoning and procedural complications | 0/26 | 3/32 | 0/3 | 2/5 | 0/2 | 0/22 | 1/3 | 1/2 | 2/23 | 3/30 | 1/33 | 7/47 | 4/25 | 0/2 | 0/1 |
| Event | NSCLC: Part I Cohort A (QW/Q2W) | NSCLC: Part I Cohort B (QW/Q2W) | NSCLC: Part I Cohort D, Arm 1 (QW/Q2W) | NSCLC: Part I Cohort D, Arm 2 (Q3W) | NSCLC: Part I Cohort D, Arm 3 (Q3W) | NSCLC: Part I Cohort F (Q3W) | NSCLC: Part II Cohort E, Arm 1 (QW/Q2W) | NSCLC: Part II Cohort E, Arm 2 (Q3W) | SCCHN: Part III Cohort G (Q3W) | SCCHN: Part III Cohort H (Q3W) | ESCC: Part III Cohort I (Q3W) | CSCC: Part III Cohort J (Q3W) | SCCHN: Part III Cohort K (QW/Q2W) | ESCC: Part III Cohort M (QW/Q2W) | CSCC: Part III Cohort N (QW/Q2W) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| HYPERTHYROIDISMEndocrine disorders | 4/26 | 0/32 | 0/3 | 0/5 | 0/2 | 0/22 | 3/3 | 0/2 | 1/23 | 0/30 | 1/33 | 4/47 | 1/25 | 0/2 | 0/1 |
| CONSTIPATIONGastrointestinal disorders | 2/26 | 3/32 | 0/3 | 1/5 | 0/2 | 2/22 | 0/3 | 0/2 | 5/23 | 4/30 | 6/33 | 6/47 | 0/25 | 2/2 | 0/1 |
| NAUSEAGastrointestinal disorders | 11/26 | 10/32 | 1/3 | 0/5 | 0/2 | 8/22 | 2/3 | 0/2 | 6/23 | 7/30 | 13/33 | 19/47 | 11/25 | 0/2 | 1/1 |
| VOMITINGGastrointestinal disorders | 10/26 | 7/32 | 1/3 | 1/5 | 0/2 | 11/22 | 0/3 | 0/2 | 5/23 | 5/30 | 3/33 | 18/47 | 1/25 | 0/2 | 1/1 |
| CHILLSGeneral disorders | 12/26 | 12/32 | 1/3 | 2/5 | 0/2 | 9/22 | 1/3 | 0/2 | 6/23 | 10/30 | 12/33 | 12/47 | 9/25 | 2/2 | 1/1 |
| FATIGUEGeneral disorders | 14/26 | 15/32 | 0/3 | 1/5 | 0/2 | 3/22 | 1/3 | 1/2 | 6/23 | 5/30 | 8/33 | 9/47 | 11/25 | 0/2 | 1/1 |
| PYREXIAGeneral disorders | 20/26 | 29/32 | 3/3 | 5/5 | 1/2 | 15/22 | 2/3 | 1/2 | 18/23 | 22/30 | 26/33 | 35/47 | 21/25 | 2/2 | 1/1 |
| BLOOD BILIRUBIN INCREASEDInvestigations | 6/26 | 6/32 | 0/3 | 0/5 | 0/2 | 1/22 | 3/3 | 0/2 | 5/23 | 2/30 | 6/33 | 12/47 | 6/25 | 0/2 | 0/1 |
| WEIGHT INCREASEDInvestigations | 0/26 | 0/32 | 0/3 | 0/5 | 0/2 | 0/22 | 0/3 | 0/2 | 0/23 | 0/30 | 0/33 | 0/47 | 0/25 | 0/2 | 1/1 |
| BACK PAINMusculoskeletal and connective tissue disorders | 7/26 | 2/32 | 0/3 | 0/5 | 0/2 | 0/22 | 0/3 | 0/2 | 0/23 | 0/30 | 3/33 | 9/47 | 0/25 | 0/2 | 1/1 |
Safety population included all participants who received at least one dose of study treatment, whether or not prematurely withdrawn from the study.
| Age, Continuous(years) | NSCLC: Part I Cohort A (QW/Q2W) | NSCLC: Part I Cohort B (QW/Q2W) | NSCLC: Part I Cohort D, Arm 1 (QW/Q2W) | NSCLC: Part I Cohort D, Arm 2 (Q3W) | NSCLC: Part I Cohort D, Arm 3 (Q3W) | NSCLC: Part I Cohort F (Q3W) | NSCLC: Part II Cohort E, Arm 1 (QW/Q2W) | NSCLC: Part II Cohort E, Arm 2 (Q3W) | SCCHN: Part III Cohort G (Q3W) | SCCHN: Part III Cohort H (Q3W) | ESCC: Part III Cohort I (Q3W) | CSCC: Part III Cohort J (Q3W) | SCCHN: Part III Cohort K (QW/Q2W) | ESCC: Part III Cohort M (QW/Q2W) | CSCC: Part III Cohort N (QW/Q2W) | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mean | 58.0 ± 10.5 | 59.8 ± 9.9 | 63.7 ± 3.8 | 65.6 ± 4.3 | 63.5 ± 4.9 | 57.4 ± 8.9 | 56.7 ± 0.6 | 68.0 ± 2.8 | 55.7 ± 12.8 | 58.8 ± 8.2 | 63.1 ± 9.6 | 51.3 ± 11.2 | 55.8 ± 11.7 | 67.0 ± 15.6 | 49.0 ± NA | 57.6 ± 10.8 |
| Sex: Female, Male(Participants) | NSCLC: Part I Cohort A (QW/Q2W) | NSCLC: Part I Cohort B (QW/Q2W) | NSCLC: Part I Cohort D, Arm 1 (QW/Q2W) | NSCLC: Part I Cohort D, Arm 2 (Q3W) | NSCLC: Part I Cohort D, Arm 3 (Q3W) | NSCLC: Part I Cohort F (Q3W) | NSCLC: Part II Cohort E, Arm 1 (QW/Q2W) | NSCLC: Part II Cohort E, Arm 2 (Q3W) | SCCHN: Part III Cohort G (Q3W) | SCCHN: Part III Cohort H (Q3W) | ESCC: Part III Cohort I (Q3W) | CSCC: Part III Cohort J (Q3W) | SCCHN: Part III Cohort K (QW/Q2W) | ESCC: Part III Cohort M (QW/Q2W) | CSCC: Part III Cohort N (QW/Q2W) | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Female | 10 | 10 | 1 | 0 | 1 | 11 | 1 | 0 | 5 | 7 | 10 | 47 | 6 | 0 | 1 | 110 |
| Male | 16 | 22 | 2 | 5 | 1 | 11 | 2 | 2 | 18 | 23 | 23 | 0 | 19 | 2 | 0 | 146 |
| Race (NIH/OMB)(Participants) | NSCLC: Part I Cohort A (QW/Q2W) | NSCLC: Part I Cohort B (QW/Q2W) | NSCLC: Part I Cohort D, Arm 1 (QW/Q2W) | NSCLC: Part I Cohort D, Arm 2 (Q3W) | NSCLC: Part I Cohort D, Arm 3 (Q3W) | NSCLC: Part I Cohort F (Q3W) | NSCLC: Part II Cohort E, Arm 1 (QW/Q2W) | NSCLC: Part II Cohort E, Arm 2 (Q3W) | SCCHN: Part III Cohort G (Q3W) | SCCHN: Part III Cohort H (Q3W) | ESCC: Part III Cohort I (Q3W) | CSCC: Part III Cohort J (Q3W) | SCCHN: Part III Cohort K (QW/Q2W) | ESCC: Part III Cohort M (QW/Q2W) | CSCC: Part III Cohort N (QW/Q2W) | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 9 | 5 | 0 | 0 | 0 | 5 | 1 | 0 | 3 | 5 | 6 | 0 | 5 | 1 | 0 | 40 |
| Native Hawaiian or Other Pacific Islander | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 4 |
| Black or African American | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 2 |
| White | 15 | 26 | 3 | 5 | 2 | 17 | 2 | 2 | 19 | 16 | 22 | 33 | 18 | 0 | 1 | 181 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 8 | 5 | 13 | 2 | 1 | 0 | 29 |
| Race/Ethnicity, Customized(Participants) | NSCLC: Part I Cohort A (QW/Q2W) | NSCLC: Part I Cohort B (QW/Q2W) | NSCLC: Part I Cohort D, Arm 1 (QW/Q2W) | NSCLC: Part I Cohort D, Arm 2 (Q3W) | NSCLC: Part I Cohort D, Arm 3 (Q3W) | NSCLC: Part I Cohort F (Q3W) | NSCLC: Part II Cohort E, Arm 1 (QW/Q2W) | NSCLC: Part II Cohort E, Arm 2 (Q3W) | SCCHN: Part III Cohort G (Q3W) | SCCHN: Part III Cohort H (Q3W) | ESCC: Part III Cohort I (Q3W) | CSCC: Part III Cohort J (Q3W) | SCCHN: Part III Cohort K (QW/Q2W) | ESCC: Part III Cohort M (QW/Q2W) | CSCC: Part III Cohort N (QW/Q2W) | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 3 |
| Not Hispanic or Latino | 23 | 28 | 3 | 4 | 2 | 20 | 3 | 2 | 22 | 21 | 27 | 33 | 23 | 1 | 1 | 213 |
| Not Stated | 1 | 2 | 0 | 1 | 0 | 1 | 0 | 0 | 1 | 7 | 4 | 9 | 2 | 1 | 0 | 29 |
| Unknown | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 5 | 0 | 0 | 0 | 11 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Ran from Feb 2018 to primary completion in Dec 2021, 46 months.
Results were first posted in Feb 2023, 1 year 1 month after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Simlukafusp alfa · Gemcitabine · Vinorelbine